Micro-infusion device and infusion set

ABSTRACT

Systems and methods of micro-infusion of medical fluids are disclosed. Micro-infusion systems may include a pump, a patient interface, tubing between the pump and the interface, and a micro-infusion device along the tubing. A first portion of the tubing above the micro-infusion device is longer than a second portion of the tubing below the device. The micro-infusion device may include a chamber in-line with the tubing, a first valve between the chamber and the first portion of the tubing, a second valve between the chamber and the second portion of the tubing and a third valve between the chamber and a dump chamber. The second valve may be slidably disposed within the chamber. A medical fluid may be provided into the chamber that slides the second valve displacing another fluid in the chamber through the third valve into the dump chamber.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of patent application Ser. No.15/414,556, filed on Jan. 24, 2017, entitled “MICRO-INFUSION DEVICE ANDINFUSION SET,” now U.S. Pat. No. 10,314,966, which issued on Jun. 11,2019, which claims the benefit of priority under 35 U.S.C. § 119 as anonprovisional of U.S. Provisional Patent Application Ser. No.62/287,840, filed on Jan. 27, 2016, entitled “MICRO-INFUSION DEVICE ANDINFUSION SET,” the disclosures of which are hereby incorporated byreference in their entirety for all purposes.

TECHNICAL FIELD

The present disclosure generally relates to the administration ofmedical fluid by infusion and, in particular, relates to systems andmethods for providing and pumping medical fluid.

BACKGROUND

Infusion pumps have become commonplace within the healthcare industry asdevices for precisely administering intravenous (IV) fluids. Use of apump in place of an elevated fluid container with a simple roller clampto control the flow of the IV fluid allows more accurate and consistentcontrol of the rate of delivery of the fluid to the patient.

The assembly of tubing, valves, fittings, and needles that connect thefluid container to the patient may be referred to as an “IV set.” IVsets are typically disposable to reduce the risk of infection andcontamination. In some infusion pump/IV set systems, a drug for deliveryto the patient is provided at or above the pump. In these systems, afluid such as saline that fills the tubing between the pump and thepatient is thus provided to the patient before any of the drug reachesthe patient. In some systems, a milliliter or more of fluid can bedisposed in the tube which, pumping at one milliliter per hour, cancause a delay of up to one hour before the drug reaches the patient.These systems can be undesirable in some situations if care is nottaken.

SUMMARY

Aspects of the subject technology relate to micro-infusion of medicalfluids using a micro-infusion device. The micro-infusion device mayinclude one or more chambers, one or more fixed valves, and one or moresliding valves and may be disposed in an intravenous (IV) set between aninfusion pump and a patient. As described in greater detail hereinafter,the valves and chambers of the micro-infusion device may be arranged andconfigured to facilitate infusion of a medical fluid to a patientwithout the need to provide large volumes of saline or other solutionsto the patient.

In accordance with certain aspects, a micro-infusion device is providedthat includes a first chamber having an input port and an output port.The micro-infusion device also includes a first valve disposed betweenthe input port and the first chamber. The micro-infusion device alsoincludes a second valve disposed on a moveable piston that is moveablewithin the first chamber. The micro-infusion device also includes asecond chamber disposed adjacent the first chamber. The micro-infusiondevice also includes a third valve disposed between the first chamberand the second chamber. The micro-infusion device also includes aneedle-free port configured to be fluidly coupled to the first chamber.

In accordance with certain aspects, an intravenous (IV) set is providedthat includes first tubing configured to be coupled to a fluid source.The IV set also includes a micro-infusion device having an input portcoupled to the first tubing. The micro-infusion device also includes afirst chamber having an input port and an output port, a first valvedisposed between the input port and the first chamber, a second valvedisposed on a moveable piston that is moveable within the first chamber,a second chamber disposed adjacent the first chamber, a third valvedisposed between the first chamber and the second chamber, a needle-freeport having a port chamber that is fluidly coupled to the first chamber,and an output port. The IV set also includes second tubing coupled tothe output port.

In accordance with certain aspects, a method is provided that includesproviding a first fluid through a first chamber and an output port of amicro-infusion device with an infusion pump. The method also includesproviding a second fluid into the first chamber from a port that isfluidly coupled to the first chamber. The method also includesdisplacing, by providing the second fluid, a portion of the first fluidin the first chamber into a second chamber. The method also includesproviding the second fluid from the first chamber through the outputport with the infusion pump.

It is understood that various configurations of the subject technologywill become readily apparent to those skilled in the art from thedisclosure, wherein various configurations of the subject technology areshown and described by way of illustration. As will be realized, thesubject technology is capable of other and different configurations andits several details are capable of modification in various otherrespects, all without departing from the scope of the subjecttechnology. Accordingly, the summary, drawings and detailed descriptionare to be regarded as illustrative in nature and not as restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included to provide furtherunderstanding and are incorporated in and constitute a part of thisspecification, illustrate disclosed embodiments and together with thedescription serve to explain the principles of the disclosedembodiments. In the drawings:

FIG. 1 is a diagram of a system for administering medical fluid to apatient using an IV pump and a micro-infusion device according tocertain aspects of the present disclosure.

FIG. 2 illustrates a cross-sectional side view of a micro-infusiondevice according to certain aspects of the present disclosure.

FIG. 3 illustrates cross-sectional side view of a syringe according tocertain aspects of the present disclosure.

FIGS. 4A-4D illustrate cross-sectional side views of a micro-infusiondevice in various configurations according to certain aspects of thepresent disclosure.

FIG. 5 illustrates an enlarged cross-sectional side view of a portion ofthe micro-infusion device of FIG. 4B according to certain aspects of thepresent disclosure.

FIG. 6 illustrates a cross-sectional side view of a micro-infusiondevice with an output port in a dump chamber according to certainaspects of the present disclosure.

FIG. 7 illustrates a cross-sectional side view of a micro-infusiondevice according to certain aspects of the present disclosure.

FIG. 8 illustrates a cross-sectional side view of a micro-infusiondevice according to certain aspects of the present disclosure.

FIG. 9 illustrates top view of a portion of a pump cassette according tocertain aspects of the present disclosure.

FIG. 10 illustrates a flow diagram of an example process formicro-infusion in accordance with various aspects of the subjecttechnology.

DETAILED DESCRIPTION

The detailed description set forth below describes variousconfigurations of the subject technology and is not intended torepresent the only configurations in which the subject technology may bepracticed. The detailed description includes specific details for thepurpose of providing a thorough understanding of the subject technology.Accordingly, dimensions may be provided in regard to certain aspects asnon-limiting examples. However, it will be apparent to those skilled inthe art that the subject technology may be practiced without thesespecific details. In some instances, well-known structures andcomponents are shown in block diagram form in order to avoid obscuringthe concepts of the subject technology.

It is to be understood that the present disclosure includes examples ofthe subject technology and does not limit the scope of the appendedclaims. Various aspects of the subject technology will now be disclosedaccording to particular but non-limiting examples. Various embodimentsdescribed in the present disclosure may be carried out in different waysand variations, and in accordance with a desired application orimplementation.

In the following detailed description, numerous specific details are setforth to provide a full understanding of the present disclosure. It willbe apparent, however, to one ordinarily skilled in the art thatembodiments of the present disclosure may be practiced without some ofthe specific details. In other instances, well-known structures andtechniques have not been shown in detail so as not to obscure thedisclosure.

According to various embodiments, a micro-infusion device is provided.The micro-infusion device may be provided at a location along aninfusion line between an infusion pump and a patient. The micro-infusiondevice may facilitate delivery of a volume of drug dose to the patient(e.g., a baby such as a prematurely-born baby), without large volumesfor priming or flushing the infusion line. The micro-infusion device maybe used to deliver the drug dose into the infusion line at a locationthat is close to the patient to reduce time to delivery initiation,while still allowing the delivery rate to be controlled by the pump andallowing a seamless return to, for example, saline delivery (or deliveryof any other administered drug compatible with the microinfusionsolution, such as D5W) upon completion of the dose delivery. Themicro-infusion device may also provide the additional benefit ofallowing observing of the progress of the dose delivery in someembodiments. The micro-infusion device may be configured to facilitatedelivery of target volumes of between, for example, 0.5 cc and 5 cc atflow rates between 0.05 cc/hr or 0.1 cc/hr and 10 cc/hr (as examples).Further details of the micro-infusion device are provided hereinafter.

While the following discussion is directed to the administration ofmedical fluid to a patient by a caregiver using an IV pump, thedisclosed methods and configurations may be used for other medical andnon-medical applications and may be used by other individuals (e.g., apatient self-administering a medical fluid at home).

FIG. 1 is a diagram of a system 100 for administering medical fluid to apatient. As shown, an infusion system 100 such as a neonatal infusionsystem may include an infusion pump 102 that controls delivery of amedical fluid to a patient 110 via tubing fluidly coupled between thepump 102 and the patient 110. In the example of FIG. 1, patient 110 is aneonate such as a prematurely-born baby or preemie.

Infusion system 100 may include a multi-chambered device such asmicro-infusion device 106 that is integrated with the tubing that runsbetween pump 102 and patient 110. Micro-infusion device 106 may be usedto provide intermittent infusions of small doses of a medication to apatient such as an infant. In the example of FIG. 1, tubing 104 fluidlycouples micro-infusion device 106 with pump 102 and tubing 108 fluidlycouples micro-infusion device 106 to patient 110. Tubing 104 may besubstantially longer than tubing 108 so that a medical fluid such as aliquid drug for patient 110 can be introduced into the tubing at alocation close to the patient. In this way, a drug dose may beintroduced into the infusion line via micro-infusion device 106 at alocation that is close to the patient to reduce time to deliveryinitiation.

A fluid such as saline or other medical fluids may be provided from pump102 to tubing 104 in a controlled matter. As shown, pump 102 may includea display 109, control features 112 and pump mechanism 114. Fluids to bepumped into tubing 104 may be provided from a fluid source located atthe pump mechanism (e.g., a syringe or vial loaded into the pumpmechanism) or via a fluid container (e.g., an IV bag) disposed above thepump and fluidly coupled through the pump via an input 116 (e.g., via alength of tubing and/or a pump cassette attached to tubing that isattached to the fluid container). Tubing of the IV set may interfacewith pump 102 via a length of tubing that is captured and manipulated bypump 102 or the IV set may include a pump cassette integrated with thetubing (superior to the microinfusion device) that is configured to bereceived in a cassette recess of the pump and that includes variousvalves, pistons, and/or other controllable components configured to beoperated by pump 102 to move fluids through the IV set. Inconfigurations in which the IV set includes a pump cassette, the pumpcassette may include a coded identifier (e.g., a bar code) or an RFIDtag that identifies the set (e.g., including identifying aspects such aschamber volumes and/or valve cracking pressures of the microinfusiondevice).

FIG. 2 shows an enlarged cross-sectional side view of micro-infusiondevice 106. As shown in FIG. 2, micro-infusion device 106 may be amulti-chambered device having a first chamber 200 and a second chamber202. Tubing 104 may be coupled to first chamber 200 by an input valve206 disposed between an input port 250 of chamber 200 and chamber 200itself. Input valve 206 may be a check valve that allows fluid 226(e.g., saline) to flow from tubing 104 into chamber 200, if the crackingpressure of valve 206 is reached, and that prevents flow of fluid fromchamber 200 into tubing 104.

A second valve such as sliding output valve 208 may also be provided inchamber 200. As shown, sliding output valve 208 may be attached to amoveable piston 210 that is configured to move within chamber 200responsive to various fluid pressures on valve 208. Sliding output valve208 may be, for example, a check valve that allows fluid 226 to flowthrough the valve from chamber 200 to tubing 108 if the crackingpressure of the valve 208 is reached when the piston 210 and valve 208are located at the bottom of chamber 200 as in the configuration of FIG.2. Tubing 108 may be coupled to chamber 200 at an output port 252.

An input port 204 such as a needle-free valve may also be coupled tochamber 200 via fluid pathway 240. Needle-free valve 204 may, forexample, be a SmartSite® needle-free valve as provided by Becton,Dickinson and Company. As shown in FIG. 2, needle-free valve 204 mayinclude a compressible valve member 205 (e.g., a silicone valve member)disposed in a chamber 207. As discussed in further detail hereinafter, amedical fluid such as a liquid drug can be introduced into chamber 200via needle-free port 204 for delivery to the patient. Pistondisplacement of liquid in chamber 200 (e.g., by movement of piston 210and valve 208) occurs when fluid is introduced through needle-free valve204, with direct flow through piston 210 impeded by valve 208.

In various embodiments, tubing 104 and 108 and device 106 may be primedprior to coupling of tubing 108 to the patient. Priming the system mayinclude using a syringe above device 106 to generate sufficient pressureto crack valves 206 and 208 to allow fluid to flow into chamber 200 andtubing 108 and/or utilizing a defeat mechanism (not explicitly shown) onvalve 208 to allow the fluid to flow into chamber 200 and tubing 108.

Device 106 may include an additional valve 220 disposed between chamber200 and chamber 202 that allows fluid 226 to flow from chamber 200 intochamber 202 when the cracking pressure of valve 220 (e.g., a checkvalve) is reached. Valve 220 also prevents flow of fluid from chamber202 into chamber 200. In this way, chamber 202 may be configured as anoverflow chamber or dump chamber so that fluid such as fluid 226 can bedumped from chamber 200 into chamber 202. As shown, valve 220 may bedisposed at the at an end (e.g., a top end or a pump-side end of a wallthat separates chambers 200 and 202) that is distal to the end at whichport 204 and fluid pathway 240 are formed (e.g., a bottom end or apatient-side end). With this configuration of chambers 200 and 202 andvalve 220, only fluid located at the top (pump side) of the chamber 200can be pushed through valve 220 into chamber 202. With thisconfiguration of chambers 200 and 202 and valve 220, the full volume ofchamber 200 can be passed into the dump chamber 202 as the microinfuseris charged with a drug from port 204 or line 108. In the configurationshown in FIG. 2, piston-mounted valve 208 is prevented, by piston 210from moving past (e.g., above) valve 220. With this configuration ofchambers 200 and 202 and valves 208 and 220, only fluid located abovevalve 208 and piston 210 (e.g., fluid 226) can pass through valve 220,and fluid introduced into chamber 200 from port 204 or line 108 may beprevented from passing through valve 220 into chamber 202 bypiston-mounted valve 208.

A vent such as vent 222 may be provided at the top (e.g., pump side) ofchamber 202 that allows air in chamber 202 to escape to the externalenvironment if displaced by fluid 226 flowing into chamber 202 fromchamber 200. A filter 224 may be provided in the vent 222 to preventcontaminants from flowing into or out of chamber 202 and to prevent dumpliquid from being ejected from the chamber while permitting air to exit.Exit of air through vent 222 prevents a pressure build up in the dumpchamber. Filter 224 may be, for example, a sterilizing quality filtersuch as a 0.2 micron filter, a check valve, and/or ahydrophobic/hydrophilic membrane or the like that prevents loss of fluidfrom chamber 202 while allowing air to exit from chamber 202. A 0.2micron filter may be used to prevent microbial contamination of theenvironment by the exiting air. A medical fluid such as a liquid drug tobe administered to the patient may be provided into chamber 200 via asource such as a syringe that is attached to port 204. FIG. 3 shows across-sectional view of an example of a needle-free syringe 300 filled(e.g., at a pharmacy or by a caregiver) with a medical fluid 302 (e.g.,a liquid drug). A plunger 306 may be configured to be compressed toprovide fluid 302 through a needle-free output port 304 of the syringe.

Referring again to FIG. 2, in various embodiments, chambers 200 and 202may each be configured to hold between, for example, 10 cc and 20 cc offluid. Chambers 200 and 202 may have a common volume or may havedifferent volumes. Chamber 202 may have a volume determined by thenumber of doses the micro-infusion device is expected to be used for.For example, device 106 may be configured to be used for infusion of twodoses of a medication without being replaced. In this example, chamber202 may have a volume of approximately 2.5 times the volume of theexpected dose, so that a volume of fluid 226 equal to the volume two ofdoses of the liquid drug can be stored within chamber 202. The exampleof two doses is merely illustrative. In some embodiments, the number ofdoses may be chosen based on a frequency of the intended infusion andthe length of a nursing shift, so that a single IV set with a singlemicro-infusion device can be used throughout a nursing shift.

The cracking pressures of valves 206, 208, and 220 may configured sothat valve 206 has the lowest cracking pressure, valve 220 has thehighest cracking pressure, and valve 208 has a cracking pressure betweenthe cracking pressure of valves 206 and 220 for proper control of fluidsthrough device 106. As examples, valve 206 may have a cracking pressureof less than 2 psi, valve 208 may have a cracking pressure of between 5psi and 10 psi, and valve 220 may have a cracking pressure equal to orabove the maximum pump pressure of the pump (e.g., equal to or aboveapproximately 20 psi). In this way, the pump can provide pressure tomove fluid 226 through valves 206 and 208 without cracking valve 220.Valve 220 may be configured to crack in response to pressure generatedby a syringe attached to port 204. Valve 208 may have a crackingpressure that is greater than the pressure required to slide piston 210(to which valve 208 is attached) within chamber 200. In this way, valve208 may be configured to be moved to the bottom of chamber 200 (as inthe configuration of FIG. 2) by fluid 226 before valve 208 is cracked.However, the above examples in which the cracking pressure of valve 206is less that the cracking pressure of valve 208 are merely illustrative.In these examples, the cracking pressure of the valve 206 is low toprevent occlusion alarms. However, in some embodiments, valve 206 mayhave a cracking pressure equal to or greater than the cracking pressureof valve 208 and less than the cracking pressure of valve 220.

The IV set that includes device 106 may have a set ID that can bescanned or otherwise provided to pump 102. Upon set recognition by thepump based on the set ID, pump 102 may reconfigure the maximum pumppressure to allow a reasonable cracking pressure of valve 220, tofacilitate filling the chamber 200 (e.g., to reduce the syringe forcenecessary to displace piston 210). Moreover, medication errors can bereduced due to the combination of a set ID and microinfusion technologydisclosed herein. For example, with a set ID (e.g., a cassette barcodeor RFID), the pump 102 may identify a microinfusion set which isassociated with a specific dosed medication and tubing chamber volumesand can monitor line pressures and/or infused volumes to ensure properdelivery of the expected dose.

FIGS. 4A, 4B, 4C, and 4D show cross-sectional side views ofmicro-infusion device 106 in various stages of operation during infusionof a medical fluid to a patient.

In the configuration of FIG. 4A, fluid 226 is flowing from tubing 104,through valve 206 (as indicated by arrow 400), through chamber 200 (asindicated by arrow 402), and through valve 208 (as indicated by arrow404) into output tubing 108 (e.g., to the patient) under control of pump102 (see FIG. 1).

In the configuration of FIG. 4B, syringe 300 has been attached toneedle-free valve 204, plunger 306 is being compressed (as indicated byarrow 412), and medical fluid 302 is being pushed into chamber 200 (asindicated by arrow 410). In this configuration, chamber 200 may have aproximal (e.g., pump-side) portion 450 behind/above piston 210 and adistal (e.g., patient-side) portion 452 in front of (below) piston 210.The distal portion 452 (when piston 210 is displaced from the fullforward position) contains the microinfuser drug 302, while proximalportion 450 behind the piston contains the IV fluid 226 only. Pressuregenerated by the flow of fluid 302 into chamber 200 has pushed piston210 and valve 208 upward in the direction of valve 206. Because valve206 prevents any flow backward into tubing 104 a portion 226D of fluid226 flows through valve 220 into chamber 202 (as indicated by arrow414). Fluid 226D may displace air in chamber 202 such that the air isvented to the external environment through vent 222 (as indicated byarrow 416). As shown in FIG. 4B, compressible member 205 may becompressed by syringe 300 so as to prevent flow of fluid 302 directlyfrom the syringe to the patient. In this way, fluid 302 can be providedinto chamber 200. However, in other embodiments, compressible member 205may be replaced with by other components such as a mechanism or anothertype of valve that prevents flow of fluid 302 directly from the syringeto the patient and allows fluid flow into chamber 200. Piston 210 andvalve 208 separate drug 302 from fluid 226. Piston 210 (sometimesreferred to as a plunger) may be configured so that, if piston 210 ispushed all the way to the top (pump side) of chamber 200, plunger 210blocks access to valve 220 so that drug 302 is prevented from flowinginto chamber 202. In this way, dilution of drug 302 and/or inaccuratedose delivery can be prevented.

In the configuration of FIG. 4C, syringe 300 has been removed from valve204, leaving fluid 302 in chamber 200. In this configuration, pump 102continues pumping fluid 226 into chamber 200 through valve 206 (asindicated by arrow 420) causing fluid 226 to push piston 210 and valve208 downward toward tubing 108. This downward pressure on piston 210 andvalve 208 moves piston 210 and valve 208 downward, thereby pushingmedical fluid 302 out of chamber 200 and into tubing 108 (as indicatedby arrow 422) (e.g., to be delivered to the patient) under control ofpump 102.

In the configuration of FIG. 4D, all of the medical fluid 302 has beenpushed from chamber 200 (e.g., and delivered to the patient) and fluid226 seamlessly follows fluid 302 from chamber 200 when piston 210 andvalve 208 reach the bottom of chamber 200 to resume providing fluid 226through device 106 (e.g., to the patient). In this configuration, fluid226 is again flowing through valve 206 (as indicated by arrow 430),through chamber 200 (as indicated by arrow 432), and through valve 208(as indicated by arrow 434) into output tubing 108 (e.g., to thepatient) under control of pump 102 while the dumped portion 226D offluid 226 remains within chamber 202. As shown in FIG. 4D, the amount offluid 226D dumped into chamber 202 may be less than half the volume ofthe chamber so that an additional dose can be provided in the samemanner described above in connection with FIGS. 4A-4C without replacingthe IV set or micro-infusion device 106. Because the amount of fluid226D in chamber 202 is equal to the amount of drug pushed into chamber200 and provided to the patient, the amount of drug provided and/or thenumber of doses provided can be measured by viewing the amount of fluid226D in chamber 202 and/or by viewing a witness line or “fiducial line”formed by the front of the stopper/plunger 210.

As shown in FIG. 4D, chamber 207 may be fluidly coupled to chamber 200so that fluid 226 automatically flushes chamber 200, chamber 207, andtubing 108 when fluid 226 is pushed through device 106 followingadministration of fluid 302 to the patient.

FIG. 5 is an enlarged cross sectional view of a portion ofmicro-infusion device 106 in the configuration of FIG. 4B with syringe300 attached to port 204. As shown in FIG. 5, when syringe 300 isattached to port 204, output port 304 of syringe 300 compressescompressible member 205 such that a pathway 502 is opened for fluid 302to flow from syringe 300 into chamber 200 and such that a forwardportion 500 of compressible member 205 extends into pathway 240 to closepathway 240, thereby blocking fluid 302 from being provided directly tothe patient from syringe 300 and separating fluid 302 from being dilutedby fluid 226.

In the embodiments described above, fluid 226D that is dumped fromchamber 200 into chamber 202 when medical fluid 302 is introduced intochamber 202 is merely stored within chamber 202 until the IV set,including device 106 is removed and replaced. However, this is merelyillustrative. As shown in FIG. 6, in some embodiments, chamber 202 maybe provided with an output port 600 such as another needle-free valve(e.g., a SmartSite® valve or an open Luer port with a cap) through whicha caretaker such as a nurse can remove fluid 226 from chamber 202 (e.g.,by connecting a needle-free syringe to port 600). In this embodiment,when fluid 226D is removed from chamber 202, air may flow into chamber202 via vent 222. The low resistance to air flow of filter 224 comparedto the high cracking pressure of valve 220 prevents fluid from beingpulled from chamber 200.

In various other embodiments, chamber 202, separated from chamber 200 byvalve 220, may be implemented as a remote chamber that is fluidicallyconnected to chamber 200 by tubing. In these embodiments, a benefit maybe provided that the second (overflow) chamber could be much larger thanthe first chamber 200 (e.g., to hold the overflow from many doses).Moreover, providing a remote chamber may help remove a large volume awayfrom the patient's immediate space. In yet another embodiment, chamber202, separated from chamber 200 by valve 220, may be replaced by asyringe coupled to chamber 200.

As noted above, it can be desirable to be able to observe the progressof the dose delivery during delivery of the dose. As shown in FIG. 7,chamber 200 may be provided with graduated markings 700 so that acaretaker can directly measure how much of drug 302 has been providedinto chamber 200 and monitor how much of the drug has subsequently beendelivered to the patient at any time (e.g., by observing the plungerfiducial line on or relative to the graduated markings).

As shown in FIG. 8, in another embodiment, chamber 202 may havegraduated markings 800 so that the amount of drug 302 that has beenintroduced into chamber 200 can be indirectly measured by observing theamount of fluid 226D in chamber 202. In this way, a record of the amountof drug 302 that has been provided can be stored by the fluid 226D inchamber 202 as the amount of fluid 226D in chamber 202 will not changeas fluid 302 is delivered to the patient or after delivery of fluid 302.In other embodiments, both chambers 200 and 202 may be provided withgraduated markings so that real time observation (e.g., using markings700) of the amount of drug 302 being delivered and a historical record(e.g., using markings 800) of the amount of drug 302 infused can beprovided.

Device 106 may be provided as an integral part of an IV set (e.g., an IVset including tubing 104 and 108, a fluid container connected to tubing104, and/or a catheter assembly). The IV set may include a cartridgecoupled to tubing 104, the cartridge configured to be installed in pump102 and manipulated thereby to pump fluid into tubing 104. As shown inFIG. 9, a cartridge 900 may have an identifier 902 (e.g., a bar code orother coded identifier, or radio frequency identification (RFID)including a set identifier (ID) and/or a set type) that identifies tothe components of the IV set, including the micro-infusion device. Inthis way, pump 102 may be provided with the characteristics of themicro-infusion device and may be able to set operating limits andconfigure sensors to detect any operational problems in the IV set,including in the micro-infusion device. Examples of operational limitsand the use thereof based on characteristics of a medical device coupledto an infusion pump can be found, for example, in U.S. Pat. No.8,038,593 which is hereby incorporated by reference herein in itsentirety.

FIG. 10 depicts a flow diagram of an example process for micro-infusion,according to aspects of the subject technology. For explanatorypurposes, the example process of FIG. 10 is described herein withreference to the components of FIG. 1-FIG. 9. Further for explanatorypurposes, the blocks of the example process of FIG. 10 are describedherein as occurring in series, or linearly. However, multiple blocks ofthe example process of FIG. 10 may occur in parallel. In addition, theblocks of the example process of FIG. 10 need not be performed in theorder shown and/or one or more of the blocks of the example process ofFIG. 10 need not be performed.

In the depicted example flow diagram, at block 1000, a first fluid(e.g., a saline solution such as fluid 226 as described herein) may beprovided through a first chamber such as chamber 200 and an output portsuch as output port 252 of a micro-infusion device such asmicro-infusion device 106 with an infusion pump such as infusion pump102. For example, the first fluid may be provided through the outputport to a patient (e.g., via tubing such as tubing 108 coupled to theoutput port and a catheter at the patient). Providing the first fluidthrough the first chamber of the micro-infusion device with the infusionpump may include providing the first fluid through a first valve such asvalve 206 into the first chamber and providing the first fluid out ofthe first chamber through a second valve such as valve 208 that isdisposed on a moveable piston such as moveable piston 210.

At block 1002, a second fluid such as a liquid drug (e.g., fluid 302 asdescribed herein) may be provided into the first chamber from a portsuch as port 204 that is fluidly coupled to the first chamber. Providingthe second fluid into the first chamber from the port that is fluidlycoupled to the first chamber may include compressing a compressiblemember of the port to open a fluid pathway between a syringe and thefirst chamber and to close a fluid pathway between the first chamber andthe output port.

At block 1004, at least a portion of the first fluid in the firstchamber may be displaced into a second chamber (e.g., chamber 202) byproviding the second fluid. Air in the second chamber may be displacedthrough a vent such as vent 222 in the second chamber with the portionof the first fluid. Displacing, by providing the second fluid, a portionof the first fluid in the first chamber into the second chamber mayinclude pushing, with the second fluid, the moveable piston and thesecond valve toward the first valve. Displacing, by providing the secondfluid, a portion of the first fluid in the first chamber into the secondchamber may also include pushing, with the moveable piston and thesecond valve, the portion of the first fluid through a third valve suchas valve 220 disposed between the first chamber and the second chamber.

At block 1006, the second fluid may be provided from the first chamberthrough the output port with the infusion pump. Following the providingof the second fluid, additional first fluid may be provided through thefirst chamber and the output port while the portion of the first fluidremains in the second chamber. In some scenarios, the portion of thefirst fluid may be removed from the second chamber via a port such asport 600 in the second chamber.

The subject technology is illustrated, for example, according to variousaspects described above. Various examples of these aspects are describedas numbered concepts or clauses (1, 2, 3, etc.) for convenience. Theseconcepts or clauses are provided as examples and do not limit thesubject technology. It is noted that any of the dependent concepts maybe combined in any combination with each other or one or more otherindependent concepts, to form an independent concept. The following is anon-limiting summary of some concepts presented herein:

Concept 1. A micro-infusion device, comprising:

-   -   a first chamber having an input port and an output port;    -   a first valve disposed between the input port and the first        chamber;    -   a second valve disposed on a moveable piston that is moveable        within the first chamber;    -   a second chamber disposed adjacent the first chamber;    -   a third valve disposed between the first chamber and the second        chamber; and    -   a needle-free port configured to be fluidly coupled to the first        chamber.        Concept 2. The micro-infusion device of Concept 1 or any other        Concept, wherein the first valve, the second valve, and the        third valve are each check valves.        Concept 3. The micro-infusion device of Concept 2 or any other        Concept, wherein the first valve has a first cracking pressure,        wherein the second valve has a second cracking pressure, wherein        the third valve has a third cracking pressure, wherein the first        cracking pressure is less than the second cracking pressure, and        wherein the second cracking pressure is less than the third        cracking pressure.        Concept 4. The micro-infusion device of Concept 1 or any other        Concept, further comprising a vent coupled between the second        chamber and an external environment.        Concept 5. The micro-infusion device of Concept 4 or any other        Concept, wherein the vent comprises a filter or a check valve.        Concept 6. The micro-infusion device of Concept 4 or any other        Concept, wherein the input port is configured to receive a first        fluid from first tubing coupled to the input port.        Concept 7. The micro-infusion device of Concept 6 or any other        Concept, wherein the moveable piston is configured to be moved        toward the first valve by a second fluid introduced at the        needle-free port and to push a portion of the first fluid        through the third valve into the second chamber.        Concept 8. An intravenous (IV) set, comprising:    -   first tubing configured to be coupled to a fluid source;    -   a micro-infusion device having an input port coupled to the        first tubing, the micro-infusion device further comprising:        -   a first chamber having an input port and an output port,        -   a first valve disposed between the input port and the first            chamber,        -   a second valve disposed on a moveable piston within the            first chamber,        -   a second chamber disposed adjacent the first chamber,        -   a third valve disposed between the first chamber and the            second chamber,        -   a needle-free port having a port chamber that is fluidly            coupled to the first chamber, and        -   an output port; and    -   second tubing coupled to the output port.        Concept 9. The IV set of Concept 8 or any other Concept, further        comprising a pump cassette coupled to the first tubing, the pump        cassette configured to interface with an infusion pump and        having a set identifier.        Concept 10. The IV set of Concept 8 or any other Concept,        further comprising a fluid container fluidly coupled to the        first tubing.        Concept 11. The IV set of Concept 10 or any other Concept,        further comprising a catheter assembly coupled to the second        tubing.        Concept 12. The IV set of Concept 11 or any other Concept,        wherein the first tubing is longer than the second tubing.        Concept 13. A method, comprising:    -   providing a first fluid through a first chamber and an output        port of a micro-infusion device with an infusion pump;    -   providing a second fluid into the first chamber from a port that        is fluidly coupled to the first chamber;    -   displacing, by providing the second fluid, a portion of the        first fluid in the first chamber into a second chamber, and    -   providing the second fluid from the first chamber through the        output port with the infusion pump.        Concept 14. The method of Concept 13 or any other Concept,        further comprising, displacing air in the second chamber through        a vent in the second chamber with the portion of the first        fluid.        Concept 15. The method of Concept 14 or any other Concept,        further comprising, following the providing of the second fluid,        providing additional first fluid through the first chamber and        the output port while the portion of the first fluid remains in        the second chamber.        Concept 16. The method of Concept 15 or any other Concept,        further comprising removing the portion of the first fluid from        the second chamber via a port in the second chamber.        Concept 17. The method of Concept 13 or any other Concept,        wherein providing the first fluid through the first chamber of        the micro-infusion device with the infusion pump comprises        providing the first fluid through a first valve into the first        chamber and providing the first fluid out of the first chamber        through a second valve that is disposed on a moveable piston.        Concept 18. The method of Concept 17 or any other Concept,        wherein displacing, by providing the second fluid, a portion of        the first fluid in the first chamber into the second chamber        comprises pushing, with the second fluid, the moveable piston        and the second valve toward the first valve.        Concept 19. The method of Concept 18 or any other Concept,        wherein displacing, by providing the second fluid, a portion of        the first fluid in the first chamber into the second chamber        further comprises pushing, with the moveable piston and the        second valve, the portion of the first fluid through a third        valve disposed between the first chamber and the second chamber.        Concept 20. The method of Concept 13 or any other Concept,        wherein providing the second fluid into the first chamber from        the port that is fluidly coupled to the first chamber comprises        compressing a compressible member of the port to open a fluid        pathway between a syringe and the first chamber and to close a        fluid pathway between the first chamber and the output port.        Concept 21. The method of Concept 13 or any other Concept,        further comprising:    -   receiving, with the infusion pump, a set identifier that        identifies the micro-infusion device;    -   determining at least one property associated with the        micro-infusion device based on the received set identifier; and    -   operating the infusion pump, at least in part, based the        determined at least one property.        Concept 22. The method of Concept 21 or any other Concept,        wherein providing the second fluid from the first chamber        through the output port with the infusion pump comprises        operating one or more components of a pump cassette coupled to        the infusion pump, wherein the pump cassette is a part of an IV        set that includes the micro-infusion device, and wherein the        pump cassette comprises a bar code or an RFID tag including the        set identifier.

The subject technology is illustrated, for example, according to variousaspects described above. The present disclosure is provided to enableany person skilled in the art to practice the various aspects describedherein. The disclosure provides various examples of the subjecttechnology, and the subject technology is not limited to these examples.Various modifications to these aspects will be readily apparent to thoseskilled in the art, and the generic principles defined herein may beapplied to other aspects.

A reference to an element in the singular is not intended to mean “oneand only one” unless specifically so stated, but rather “one or more.”Unless specifically stated otherwise, the term “some” refers to one ormore. Pronouns in the masculine (e.g., his) include the feminine andneuter gender (e.g., her and its) and vice versa. Headings andsubheadings, if any, are used for convenience only and do not limit theinvention.

The word “exemplary” is used herein to mean “serving as an example orillustration.” Any aspect or design described herein as “exemplary” isnot necessarily to be construed as preferred or advantageous over otheraspects or designs. In one aspect, various alternative configurationsand operations described herein may be considered to be at leastequivalent.

As used herein, the phrase “at least one of” preceding a series ofitems, with the term “or” to separate any of the items, modifies thelist as a whole, rather than each item of the list. The phrase “at leastone of” does not require selection of at least one item; rather, thephrase allows a meaning that includes at least one of any one of theitems, and/or at least one of any combination of the items, and/or atleast one of each of the items. By way of example, the phrase “at leastone of A, B, or C” may refer to: only A, only B, or only C; or anycombination of A, B, and C.

A phrase such as an “aspect” does not imply that such aspect isessential to the subject technology or that such aspect applies to allconfigurations of the subject technology. A disclosure relating to anaspect may apply to all configurations, or one or more configurations.An aspect may provide one or more examples. A phrase such as an aspectmay refer to one or more aspects and vice versa. A phrase such as an“embodiment” does not imply that such embodiment is essential to thesubject technology or that such embodiment applies to all configurationsof the subject technology. A disclosure relating to an embodiment mayapply to all embodiments, or one or more embodiments. An embodiment mayprovide one or more examples. A phrase such an embodiment may refer toone or more embodiments and vice versa. A phrase such as a“configuration” does not imply that such configuration is essential tothe subject technology or that such configuration applies to allconfigurations of the subject technology. A disclosure relating to aconfiguration may apply to all configurations, or one or moreconfigurations. A configuration may provide one or more examples. Aphrase such a configuration may refer to one or more configurations andvice versa.

In one aspect, unless otherwise stated, all measurements, values,ratings, positions, magnitudes, sizes, and other specifications that areset forth in this specification, including in the claims that follow,are approximate, not exact. In one aspect, they are intended to have areasonable range that is consistent with the functions to which theyrelate and with what is customary in the art to which they pertain.

It is understood that the specific order or hierarchy of steps, oroperations in the processes or methods disclosed are illustrations ofexemplary approaches. Based upon implementation preferences orscenarios, it is understood that the specific order or hierarchy ofsteps, operations or processes may be rearranged. Some of the steps,operations or processes may be performed simultaneously. In someimplementation preferences or scenarios, certain operations may or maynot be performed. Some or all of the steps, operations, or processes maybe performed automatically, without the intervention of a user. Theaccompanying method claims present elements of the various steps,operations or processes in a sample order, and are not meant to belimited to the specific order or hierarchy presented.

All structural and functional equivalents to the elements of the variousaspects described throughout this disclosure that are known or latercome to be known to those of ordinary skill in the art are expresslyincorporated herein by reference and are intended to be encompassed bythe claims. Moreover, nothing disclosed herein is intended to bededicated to the public regardless of whether such disclosure isexplicitly recited in the claims. No claim element is to be construedunder the provisions of 35 U.S.C. § 112 (f) unless the element isexpressly recited using the phrase “means for” or, in the case of amethod claim, the element is recited using the phrase “step for.”Furthermore, to the extent that the term “include,” “have,” or the likeis used, such term is intended to be inclusive in a manner similar tothe term “comprise” as “comprise” is interpreted when employed as atransitional word in a claim.

The Title, Background, Summary, Brief Description of the Drawings andAbstract of the disclosure are hereby incorporated into the disclosureand are provided as illustrative examples of the disclosure, not asrestrictive descriptions. It is submitted with the understanding thatthey will not be used to limit the scope or meaning of the claims. Inaddition, in the Detailed Description, it can be seen that thedescription provides illustrative examples and the various features aregrouped together in various embodiments for the purpose of streamliningthe disclosure. This method of disclosure is not to be interpreted asreflecting an intention that the claimed subject matter requires morefeatures than are expressly recited in each claim. Rather, as thefollowing claims reflect, inventive subject matter lies in less than allfeatures of a single disclosed configuration or operation. The followingclaims are hereby incorporated into the Detailed Description, with eachclaim standing on its own as a separately claimed subject matter.

The claims are not intended to be limited to the aspects describedherein, but are to be accorded the full scope consistent with thelanguage of the claims and to encompass all legal equivalents.Notwithstanding, none of the claims are intended to embrace subjectmatter that fails to satisfy the requirement of 35 U.S.C. § 101, 102, or103, nor should they be interpreted in such a way.

What is claimed is:
 1. A method, comprising: providing a first fluidthrough a first chamber and an output port of a micro-infusion devicewith an infusion pump; providing a second fluid into the first chamberfrom a port that is fluidly coupled to the first chamber, displacing, byproviding the second fluid, a portion of the first fluid in the firstchamber into a second chamber; and providing the second fluid from thefirst chamber through the output port with the infusion pump.
 2. Themethod of claim 1, further comprising, displacing air in the secondchamber through a vent in the second chamber with the portion of thefirst fluid.
 3. The method of claim 2, further comprising, following theproviding of the second fluid, providing additional first fluid throughthe first chamber and the output port while the portion of the firstfluid remains in the second chamber.
 4. The method of claim 3, furthercomprising removing the portion of the first fluid from the secondchamber via a port in the second chamber.
 5. The method of claim 1,wherein providing the first fluid through the first chamber of themicro-infusion device with the infusion pump comprises providing thefirst fluid through a first valve into the first chamber and providingthe first fluid out of the first chamber through a second valve that isdisposed on a moveable piston.
 6. The method of claim 5, whereindisplacing, by providing the second fluid, a portion of the first fluidin the first chamber into the second chamber comprises pushing, with thesecond fluid, the moveable piston and the second valve toward the firstvalve.
 7. The method of claim 6, wherein displacing, by providing thesecond fluid, a portion of the first fluid in the first chamber into thesecond chamber further comprises pushing, with the moveable piston andthe second valve, the portion of the first fluid through a third valvedisposed between the first chamber and the second chamber.
 8. The methodof claim 1, wherein providing the second fluid into the first chamberfrom the port that is fluidly coupled to the first chamber comprisescompressing a compressible member of the port to open a fluid pathwaybetween a syringe and the first chamber and to close a fluid pathwaybetween the first chamber and the output port.
 9. The method of claim 1,further comprising: receiving, with the infusion pump, a set identifierthat identifies the micro-infusion device; determining at least oneproperty associated with the micro-infusion device based on the receivedset identifier; and operating the infusion pump, at least in part, basedon the determined at least one property.
 10. The method of claim 9,wherein providing the second fluid from the first chamber through theoutput port with the infusion pump comprises operating one or morecomponents of a pump cassette coupled to the infusion pump, wherein thepump cassette is a part of an IV set that includes the micro-infusiondevice, and wherein the pump cassette comprises a bar code or an RFIDtag including the set identifier.